Oral steroids for otitis media with effusion in children study (OSTRICH)

Phase 1

• Conditions: Otitis media with effusion.; MedDRA version: 14.1 Level: LLT Classification code 10040113 Term: Serous otitis media (glue ear) System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2012-005123-32-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-03-25
• Study Completion: 2017-04-27
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 380

Inclusion Criteria

•2-8 years of age (reached 2nd birthday and not yet reached 9th birthday), •Had symptoms of hearing loss attributable to OME for at least 3 months (or had audiometry proven hearing loss for at least 3 months), •Diagnosis of bilateral OME made in an ENT clinic on the day of recruitment or during the preceding week. •Audiometry confirming hearing loss of more than 20 dB averaged at 0.5, 1, 2, and 4 KHz in the better ear by pure tone audiometry in children 3 years of age or more or hearing loss of more than 25 dB averaged over 0.5, 1, 2, and 4 KHz by sound field visual reinforcement audiometry (VRA) in children less than 3 years of age, on the day of recruitment or in the preceding week.
Are the trial subjects under 18? yes
Number of subjects for this age range: 380
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Children with cleft palate, •Children with Down’s syndrome, •Children with confirmed, major developmental difficulties (e.g. are tube fed, have chromosomal abnormalities), •Children with current systemic infection (including Varicella), •Children with renal failure, hypertension or congestive heart failure, •Children with diabetes mellitus, •Children who have taken oral steroids in the preceding four weeks, •Children with a condition that increases their risk of adverse effects from oral steroids (i.e. on treatment likely to modify the immune system or who are immunocompromised), •Children with no prior history of Varicella (Chicken Pox) infection or immunisation and who have been in close contact with someone known or suspected to have Varicella or active Zoster (Shingles) during the three weeks prior to recruitment, •Children who are currently involved in another CTIMP or have participated in a CTIMP during the last 4 months. Or if they do not have: • A parent or legal guardian who is available to provide written informed consent. • A parent/legal guardian (or a person delegated by the parent/legal guardian) who expects to be available for follow up visits at 5 weeks, 6 and 12 months and who understands English well enough to complete simple verbal and written questionnaires.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified